Clinical Research is one of the most critical area in Pharmaceutical industry, which contributes greatly to the effective development of drugs by confirming their efficacy, safety and bio-equivalency. Clinical Research has a vast portfolio which includes innovation of new molecules, discovering new indications, drug design, dosage regimen, the assessment of devices for the administration of drugs, and analyzing the safety of the developed product and determining equivalence against the reference product. The field of Clinical Research involves the development of both innovative and generic products, and the criticality of the studies conducted depends upon the type of pharmaceutical formulation, the safety data provided plus the target therapeutic indications.
Regulatory Authorities have specific requirements and expectations from clinical studies when it comes to the safety and efficacy of the innovative molecules and to demonstrate their bio-equivalency with the reference product along with the application of current Good Clinical Practices (GCP). In addition, Regulatory Authorities also prescribe certain specific requirements in terms of the formats for submitting all the data generated during clinical studies as part of the dossier submission (like Investigational New Drugs [INDs], Investigational Medicinal Product Dossier [IMPDs], Clinical Trial Applications [CTAs], New Drug Applications [NDAs], New Drug Submissions [NDSs], Biological License Applications [BLAs], Abbreviated New Drug Applications [ANDAs], Abbreviated New Drug Submissions [ANDSs], Market Authorization Applications [MAAs]).
Freyr has a competent team of clinical and Regulatory experts to guide Clinical Research Organizations in Regulatory strategic consulting, Regulatory assessment or gap analysis, as well as to assist in the compilation and submission of such dossiers to various Health Authorities (HAs).